The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

— BIS-TBI  

Official title:

The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03575169
• Other study ID #: 1-063-18
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

An observational study to assess the BIS reported level of sedation of patients with traumatic brain injury in the ICU.

Description:

Patients admitted to Aberdeen ICU with severe traumatic brain injury will have a BIS electrode placed and observed for 24 hours. The study team will be blinded to the result, so not to influence treatment.

All clinical care is at the discretion of the clinical team.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults (over 18)

• Diagnosis of traumatic brain injury

• Expected to survive

• Expected to require greater than 24 hours of sedation and mechanical ventilation

Exclusion Criteria:

• Brain injury thought to be unsurvivable by ICU clinical team

• Frontal decompressive craniectomy

• Use of ketamine infusion at recruitment or planned use within 24 hours

• Fractured frontal bone or severe overlying soft tissue injury

• Simple extradural haemorrhage with no other obvious intracranial injury

• Pregnant patient

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Device:
• BIS Monitor
Unilateral BIS electrode

Locations

Country	Name	City	State
United Kingdom	Intensive Care Unit, Aberdeen Royal Infirmary	Aberdeen
United Kingdom	NHS Tayside	Dundee
United Kingdom	NHS Lothian	Edinburgh
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds

Sponsors (2)

Lead Sponsor	Collaborator
University of Aberdeen	NHS Grampian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean BIS	Mean BIS of patients sedated	24 hours
Secondary	Mean ICP	Mean ICP of sedated patient	24 hours
Secondary	Incidence of osmotherapy use	Number of instances of osmotherapy use in sedated patients	24 hours
Secondary	Vasopressor dose	Total vasopressor dose for sedated patients	24 hours
Secondary	Sedative dose	Total sedative dose for sedated patients	24 hours
Secondary	Length of ICU stay	Number of days admitted to ICU	Days to weeks